Endoscopic ultrasound fine needle fiducial system

Patent metadata

Field	Value
Publication number	US-2017100162-A1
Application number	US-201615284683-A
Country	US
Kind code	A1
Filing date	Oct 4, 2016
Priority date	Oct 7, 2015
Publication date	Apr 13, 2017
Grant date	—

Abstract

Methods, apparatuses and systems are described for implanting a plurality of fiducial markers into a tissue. Systems include a needle, a stylet sized to slide within a lumen of the needle, and a multi-stop stylet spacer having stopping features configured to engage with the stylet to stop the distal end of the stylet at one or more predetermined distances from the distal end of the needle. Methods for implanting a plurality of fiducial markers into a tissue are described and include inserting a needle preloaded with fiducial markers into a tissue, adjusting a multi-stop stylet spacer from a safety position to a first deployment position, deploying a first fiducial marker into the tissue, adjusting the stylet spacer from the first deployment position to a second deployment position, and deploying a second fiducial marker into the tissue.

First claim

1 . A device for implanting a plurality of fiducial markers into a tissue, comprising:
a needle having a proximal end, a distal end, and a lumen extending therebetween; a stylet having a proximal end and a distal end, wherein the distal end is sized to slide within the lumen of the needle; and a multi-stop stylet spacer having a plurality of stopping features configured to engage with the stylet to stop the distal end of the stylet at a plurality of predetermined distances from the distal end of the needle.

2 . The device of claim 1 , wherein the multi-stop stylet spacer is adjustable between a plurality of positions by actuating the multi-stop stylet spacer in a plane orthogonal to the proximal end of the stylet.

3 . The device of claim 2 , wherein the proximal end of the stylet engages a different stopping feature in each of the plurality of positions.

4 . The device of claim 2 , wherein the multi-stop stylet spacer is adjustable between three positions, wherein:
in a first position the proximal end of the stylet engages a first stopping feature to stop the distal end of the stylet in a first location with respect to the distal end of the needle; in a second position the proximal end of the stylet engages a second stopping feature to stop the distal end of the stylet in a second location located distal to the first location; and in a third position the proximal end of the stylet engages a third stopping feature to stop the distal end of the stylet in a third location located distal to the second location.

5 . The device of claim 4 , further comprising a plurality of fiducial markers housed within the lumen of the needle, wherein:
in the first position the first stopping feature prevents deployment of any of the plurality of fiducial markers from the distal end of the needle; and in the second position the second stopping feature permits the deployment of a first of the plurality fiducial markers while preventing the deployment of a second of the plurality of fiducial markers.

6 . The device of claim 1 , wherein the plurality of predetermined distances are based on a number and a size of a plurality of fiducial markers housed within the lumen of the needle.

7 . The device of claim 1 , wherein the plurality of stopping features of the multi-stop stylet spacer comprise a plurality of ledges arranged in a stair-stepped configuration.

8 . The device of claim 1 , further comprising a plurality of fiducial markers housed within the lumen of the needle separated by at least one fiducial marker spacer.

9 . The device of claim 1 , further comprising a fiducial marker retention member coupled with the distal end of the needle.

10 . The device of claim 9 , wherein the fiducial marker retention member comprises bone wax.

11 . The device of claim 9 , wherein the fiducial marker retention member comprises a cap configured to fit over the distal end of the needle.

12 . The device of claim 9 , wherein the fiducial marker retention member comprises one or more detents disposed within the lumen of the needle.

13 . The device of claim 1 , wherein the stylet is tapered such that the distal end has a smaller diameter than the proximal end.

14 . A system for implanting a plurality of fiducial markers into a tissue, comprising:
a handle member assembly having a proximal end, a distal end, and a lumen extending therebetween; a sheath having a proximal end, a distal end, and a lumen extending therebetween, the proximal end of the sheath being coupled with the distal end of the handle member assembly forming a continuous lumen from the proximal end of the handle member to the distal end of the sheath; a needle having a proximal end, a distal end, and a lumen extending therebetween and being sized to advance through the continuous lumen of the handle member assembly and the sheath; a plurality of fiducial markers housed within the lumen of the needle; a stylet having a proximal end and a distal end and sized to advance through the lumen of the needle; and a multi-stop stylet spacer having a plurality of stopping features configured to engage with the stylet to controllably deploy the plurality of fiducial markers from the distal end of the needle.

15 . The system of claim 14 , wherein a first of the plurality of stopping features engages with the stylet to prevent the stylet from deploying any of the plurality of fiducial markers from the distal end of the needle.

16 . The system of claim 15 , wherein a second of the plurality of stopping features engages with the stylet to permit the stylet to deploy a first fiducial marker from the distal end of the needle, and wherein a third of the plurality of stopping features engages with the stylet to permit the stylet to deploy a second fiducial marker from the distal end of the needle.

17 . The system of claim 14 , wherein the multi-stop stylet spacer is adjustable between a plurality of positions by actuating the multi-stop stylet spacer in a plane orthogonal to the proximal end of the stylet.

18 . The system of claim 17 , wherein the proximal end of the stylet engages a different stopping feature in each of the plurality of positions.

19 . The system of claim 17 , wherein the multi-stop stylet spacer is adjustable between three positions, wherein:
in a first position the proximal end of the stylet engages a first stopping feature to stop the distal end of the stylet to prevent any of the plurality of fiducial markers from being deployed from the distal end of the needle; in a second position the proximal end of the stylet engages a second stopping feature to stop the distal end of the stylet to permit the deployment of a first of the plurality fiducial markers while preventing the deployment of a second of the plurality of fiducial markers; and in a third position the proximal end of the stylet engages a third stopping feature to stop the distal end of the stylet to permit the deployment of the second of the plurality of fiducial markers.

20 . The system of claim 14 , further comprising at least one fiducial marker spacer disposed between at least two of the plurality of fiducial markers.

Assignees

• Covidien Lp

Inventors

• Campbell Eugene
• Mcweeney John O
• Tinkham Brian
• Tully Stephen J

Classifications

• A61B2090/0811

  for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument · CPC title

• A61B2090/3925

  ultrasonic · CPC title

• A61B2090/3987

  Applicators for implanting markers · CPC title

• A61B2090/0807

  Indication means · CPC title

• A61B90/39

  Markers, e.g. radio-opaque or breast lesions markers · CPC title